Senior Validation Engineer - Remote & Flexible Hours

BioSpace; Raleigh (NC); Remote; USD 120,000 - 165,000; Full time

Job summary

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP environments.

You will develop, execute and manage validation lifecycle documentation while ensuring regulatory compliance. The role includes mentoring junior staff and collaborating cross‑functionally to meet timelines and quality standards.

Qualifications

• 7–11 years in biotech, pharma, or medical device industry.
• Strong knowledge of FDA cGMP, FMEA, and risk‑based validation.
• Advanced validation expertise in equipment and computerized systems (CSV).
• Experience writing IQ, OQ, PQ, and CSV reports.
• Experience supporting audits and regulatory inspections.

Responsibilities

• Lead validation lifecycle documentation for equipment, utilities, facilities, and systems.
• Oversee validation activities for tech transfer projects and risk assessments.
• Write and review SOPs, validation master plans, URS, FRS, and design specs.
• Prepare summary reports for validation, commissioning, and requalification.
• Mentor junior validation staff and coordinate cross‑functional work.
• Support regulatory observations and remediation activities.

Skills

Validation leadership

cGMP knowledge

Risk-based validation

IQ/OQ/PQ/CSV

Technical writing

Education

Bachelor's degree in life science or engineering

Tools

CSV systems

Job description

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP environments.

You will develop, execute and manage validation lifecycle documentation while ensuring regulatory compliance. The role includes mentoring junior staff and collaborating cross‑functionally to meet timelines and quality standards.